Fresenius Medical Care 5008, Operating Instructions Manual

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Chapter 2: Important Information
2-4 Fresenius Medical Care 5008 OP 5/09.06
2.2.2 Intended Use
O
Fields of application
The 5008 hemodialysis system is designed for performing chronic and
acute hemodialysis. It can be used in home dialysis, hemodialysis and
limited care centers and clinical hemodialysis.
O
Side effects
Hemodialysis therapies occasionally cause hypotension, nausea,
vomiting and cramps in some patients. In addition, the package inserts
enclosed with the consumables (e.g. hemodialysis concentrates,
dialyzers) must be observed.
O
Contraindications
– Hyperkalemia (only with potassium-containing hemodialysis
concentrates)
– Hypokalemia (only with potassium-free hemodialysis concentrates)
– Uncontrollable coagulation anomalies
A different method of extracorporeal treatment may be indicated in
hemodynamically unstable patients.
O
Restrictions
None
2.2.3 Target Group
The system may only be installed, operated and used by persons with
the appropriate training, knowledge and experience.
2.2.4 Duties of the Responsible Organization
The responsible organization assumes the following responsibilities:
– Compliance with the national or local installation, operation, use and
maintenance regulations
– Respect of the accident prevention regulations
– Correct and safe state of the system
– Permanent availability of the Operating Instructions